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expression levels, and post-harvest processing must
be tightly controlled.
• Target tissue delivery – While mucosal targeting is
promising, not all therapeutic indications benefit
from local gut action. In some cases, systemic
uptake may still be required, raising the question:
can oral delivery ever fully replace injection?
• Complex protein folding and glycosylation –
While plant platforms can express many therapeutic
proteins, some structures—especially multimeric
antibodies—remain difficult to produce at scale
without compromising functionality.

These challenges are solvable—but only with focused
investment, smarter design, and cross-disciplinary
collaboration.

Regulatory Ambiguity

As discussed in Section 4.7, edible biologics don’t fit
neatly into current regulatory frameworks. The roadblocks
here are conceptual as much as procedural:

• Unclear categorization – Is the product a food,
drug, device, or biologic? This ambiguity can slow
progress, especially in early-stage regulatory
engagement.
• GMP expectations for plant-grown therapies –
How do regulators assess cleanliness, batch
consistency, or contamination risk in a greenhouse
or hydroponic system versus a traditional
bioreactor?
• Data standards for non-systemic efficacy – When
the mechanism of action is local or tolerogenic, how

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